We'll be on hand throughout the conference to answer any questions you may have...especially about one of our most popular offerings: QMS in a box (phase-appropriate)
QMS in a box is a foundational framework of core procedures, forms, and templates designed to support smaller US-based start-up companies currently using an outsourced supply chain model. We provide an established, phase-appropriate, and customizable QMS based on FDA’s Phase 1 GMPs that utilizes recognized cloud-based electronic document and learning management systems (integrated EDMS-LMS) to enable release of Phase 1 GMP clinical trial material. This enables Sponsors to initiate vendor qualification of GLP CROs, review and approve Quality Agreements, and conduct audits of CDMOs, either through their own internal resources or via a contracted QA resource provided by BTL/DHC. Ultimately, these procedures will be necessary for use by the Sponsor company’s Quality representative to formally release the early phase clinical lot to the clinic. Schedule an in-person conversation to learn more!
